NCT07271966 · Duke University
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy
(BALANCE)
What this study is about
This is a supportive care study to assess the effect of Vitamin B6 supplementation on mood-related side effects of levetiracetam in patients with brain tumors, who have already been prescribed levetiracetam for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver.
View original scientific description
This is a supportive care study to assess the effect of Vitamin B6 supplementation on mood-related side effects of levetiracetam in patients with brain tumors, who have already been prescribed levetiracetam for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver. Patients will receive Vitamin B6 as a supplement to take daily for 8 to 12 weeks, in addition to the already prescribed levetiracetam and will undergo study assessments as well as complete self-reported questionnaires to evaluate their mood during the course of the study. Additionally, each patient will be asked to optionally identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes, at the same time interval as the patient.
Interventions
DIETARY_SUPPLEMENT
Vitamin B6 100 MG
Patients will be prescribed 100 mg of Vitamin B6 as a supplement to take daily in the morning, by mouth for 8 to 12 weeks, in addition to the already prescribed levetiracetam.
Primary outcome measures
Efficacy of VitB6 supplementation on LEV-associated mood changes in patients with BTRE, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anger questionnaire
Time frame: From enrollment (Baseline) to follow-up at 8-12 weeks from the initiation of VitB6 supplementation
Mean change in patient-reported PROMIS anger T-scores between baseline and the 8 to 12-week follow-up visit among patients who complete questionnaires at both timepoints. Each item on the PROMIS Anger Short Form is rated on a 5-point scale. The total score can range from 5 to 25, with higher scores indicating greater severity of anger.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for Patients:
- Age ≥ 18 years
- Diagnosed with a primary brain tumor
- Karnofsky Performance Status ≥ 70%
- Have one or more documented seizures or transient events concerning for localization-related epilepsy requiring anti-seizure medication prophylaxis
- Have an active immediate release levetiracetam prescription
- Taking levetiracetam for ≥ 6 weeks and ≤ 6 months before screening
- Baseline patient-reported mood symptoms and/or National Comprehensive Cancer Network distress thermometer score ≥ 3
- Has access to e-mail where they can receive electronic informed consent form (ICF) and questionnaires
- Signed ICF approved by the institutional review board (IRB) Inclusion Criteria for Caregivers:
- Age ≥ 18 years
- Patient has indicated that it is acceptable to recruit their caregivers into the study
- Able to read and write English
- Has access to e-mail where they can receive electronic ICF and questionnaires
- Signed ICF approved by the IRB
Exclusion criteria
- for Patients:
- Active prescription for steroids at the time of enrollment
- Prescription for extended-release levetiracetam
- Previous history of suicidal ideation, homicidal ideation, hallucinations, psychosis, depression leading to hospitalization, or mood disturbance leading to hospitalization
- Prior history of alcohol use disorder or substance use disorder
- Refractory epilepsy requiring second or third line anti-seizure medication in addition to levetiracetam at the time of enrollment
- Patients who are currently pregnant or breastfeeding/chestfeeding
- Patients with a pre-existing history of neuropathy
- Known history of Vitamin B6 toxicity or deficiency
- Prior history of gastric surgery or colectomy
- Prior history of autoimmune disease, such as Crohn's, Ulcerative Colitis, or Celiac disease
- Prescribed Theophylline (Aquaphyllin, Elixophyllin, Theolair, Truxophyllin) used in the treatment of asthma, chronic bronchitis, and emphysema
- Cognitive impairment that affects the patient's ability to comprehend and provide responses to questionnaires
Where
- Durham, North Carolina
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations